Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of calcipotriol plus betamethasone dipropionate gel in psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. patients will be treated once daily for up to 8 weeks. the primary response criterion is the number of patients with controlled disease at week 8.


Eligibility criteria:
inclusion criteria: * psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week * an investigators' global assessment of disease severity of at least mild exclusion criteria: * puva or grenz ray therapy within 4 weeks prior to randomisation * uvb therapy within 2 weeks prior to randomisation * systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within 6 months prior to randomisation * systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin d analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation * any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation * topical treatment for other relevant skin disorders (except who group i-ii corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation * planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study * current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
relationship between potassium level in venous blood samples drawn and heel sticks in infants and newborns

Conditions: Hyperkalemia

Summary: the purpose of this study is to find out whether there is a correlation (link) between the level of potassium in blood samples drawn from a vein and those drawn from a heel stick in infants scheduled for elective surgery.

this is a prospective study which will take place at the children's memorial hermann hospital operating room. after obtaining written informed consent from parents or guardians, infants and babies scheduled to have elective surgery under routine general anesthesia and are \<6 months of age will be included in the study. after the baby receives routine general anesthesia, a small amount of blood, 0.5 ml, will be drawn from a vein when an i.v. is started for the surgery. the largest possible cannula will be placed whenever possible to decrease hemolysis. if a baby has a central line, the blood sample will be drawn from it. if a baby has an existing peripheral i.v., a blood sample will be drawn from the i.v. cannula only if blood is freely running, to avoid hemolysis. blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. a second blood sample, 0.3 ml, will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis. the heel will be properly sterilized, and a proper size lancet will be used. the same operator will be performing the heel stick in each case.

Eligibility criteria:
inclusion criteria: * infants and babies, asa physical status i-iii, less than 6 month of age and scheduled to have elective surgery under routine general anesthesia at children's memorial hermann hospital will be included. exclusion criteria: * babies and infants with documented anemia (\ iii, have sickle cell disease or trait, thalassemia, hiv or dic will be excluded from the study. babies with organ failure will be excluded.

Keywords: potassium infants heel stick less than or equal to 6 months of age iv catheter blood samples perioperatively elective surgical procedures
improving health care in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this project aims to improve the health care provided to people with major depressive disorder (mdd), a disease which is a top cause of disability worldwide. one of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated biological correlates. using a large sample of people with mdd already recruited (n=29,400), the investigators develop a clustering algorithm based on genetic-environmental and brain imaging predictors aimed at identifying homogeneous mdd subgroups. the researchers will then link these subgroups with relevant health outcomes, such as disease recurrency and severity, well-being and functioning, risk of psychiatric and medical comorbidities (e.g. cardiovascular disorders). replication in independent samples already recruited(n=1380) will prove the validity of the subgroups and expand their clinical characterization. the investigators will develop a classification tool to link the individual's characteristics to the relevant health outcomes and provide corresponding clinical recommendations. the prognostic support tool will be applied to newly recruited samples, feasibility and usefulness according to clinicians's opinion will be assessed (n=120, ongoing recruitment).


Eligibility criteria:
inclusion criteria: * diagnosis of depressive episode in major depressive disorder (dsm-5); * at least one depressive episode preceding the current one; * aged between 18 and 65; * score of at least 8 on the hamilton depression rating scale (hdrs); * signature of the information form and declaration of informed consent; * elementary school certificate (as a minimum requirement for understanding the questions presented in the tests); * native italian speaker (or bilingualism). exclusion criteria: * diagnosis of bipolar disorder, cyclothymic disorder, schizophrenia and other psychotic spectrum disorders, neurodevelopmental disorders; * diagnosis of intellectual disability, epilepsy, neurodegenerative disorders; * disorders related to the use of drugs or alcohol in the last 6 months (except nicotine and caffeine); * pregnant or breastfeeding.
orthopedic intelligent navigation system in the treatment of fresh femoral neck fractures

Conditions: Fracture of Neck of Femur

Summary: the goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures. participants will: * take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures. * visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, gender is not limited; 2. patients diagnosed with femoral neck fracture; 3. patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery; 4. the subject or his legal representative is informed of the nature of the study and agrees to participate in the study. exclusion criteria: 1. participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit; 2. the patient is known to have a history of allergy to one or more implanted materials; 3. patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases; 4. active infection of the hip joint or other parts of the body is determined by the investigator; 5. diagnosed as metabolic bone disease, radiation bone disease, etc.; 6. severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain; 7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.; 8. the patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate; 9. other conditions deemed unsuitable for inclusion by the investigator.

Keywords: orthopedic intelligent navigation system
til cells for the treatment of the advanced solid tumors patients

Conditions: Solid Tumor

Summary: this study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (tils) therapy in patients with advanced malignant solid tumors. tils are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

this is a single-center, open-label, phase i clinical study of tils for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy. tils are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen. the primary purpose of this study is to evaluate the safety and tolerability of tils in patients with recurrent/metastatic solid tumors. the second purpose of this study is to preliminarily explore the effectiveness of tils in patients with recurrent/metastatic solid tumors. eligibility: adults aging 18-75 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Eligibility criteria:
inclusion criteria: 1. have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail; 2. 18 \~ 75 years; 3. the expected survival period is at least 3 months; 4. ecog score of 0-1; 5. there is at least one lesion that can be operated or biopsied for the preparation of til; 6. according to recist 1.1 standard, there is at least one measurable target lesion for efficacy evaluation; 7. patients with recurrent or metastatic solid tumors confirmed by histopathology; 8. subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression exclusion criteria: 1. female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline ; 2. subjects who have had severe allergic reactions to any drug or its components in this trial in the past; 3. subjects who have received any investigational drug within 28 days before the infusion of til cells, or participated in another clinical study at the same time; 4. subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma; 5. patients who have received adoptive cell therapy in the past; 6. according to the judgment of the investigator, the condition of the subject is not suitable for this trial.
fotemustine in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. studying samples of tumor tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. purpose: this phase ii trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.

objectives: primary * assess the relationship between mgmt expression and response to fotemustine in patients with metastatic malignant melanoma. secondary * establish a value for mgmt expression below which fotemustine has a strong probability of effectiveness. outline: this is a multicenter study. patients receive induction chemotherapy comprising fotemustine iv over 1 hour on days 1, 8, and 15. beginning 5 weeks later, patients achieving stable or objective response receive maintenance chemotherapy comprising fotemustine iv over 1 hour once every 3 weeks for 6 courses. tissue samples are collected at baseline to assess level of mgmt expression by pcr. after completion of study treatment, patients are followed every 2 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic malignant melanoma, meeting the following criteria: * metastatic lymph nodes or skin allowing for surgical resection * at least 1 metastatic lesion (lymph nodes, skin, visceral, brain) * measurable or evaluable disease patient characteristics: * who performance status 0-2 * anc \> 2 x 10\^9/l * platelet count \> 100 x 10\^9/l * transaminases ≤ 2.5 times normal * alkaline phosphate ≤ 2.5 times normal * total bilirubin normal * not pregnant or nursing * fertile patients must use effective contraception * no severe uncontrolled infection * no other prior or concurrent malignancy (except basal cell or squamous cell carcinoma in situ of the cervix that was curatively treated) prior concurrent therapy: * no prior chemotherapy * at least 2 weeks since prior adjuvant therapy * at least 4 weeks since prior radiotherapy * at least 30 days since prior participation in another clinical trial * no prior or concurrent prophylactic phenytoin

Keywords: recurrent melanoma stage iv melanoma
comparative evaluation of class v restorations

Conditions: Secondary Caries; Dental Restoration Failure of Marginal Integrity

Summary: to evaluate and compare the 2-year clinical performance of class v restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding

the experimental design description adhered to the guidelines provided by the consolidated standards of reporting trials (consort) statement. the present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. the trial will follow a parallel design. a total of one hundred adult patients, who are seeking dental treatment, will be enrolled in the study. the participants will be recruited from the operative department clinic at the faculty of dentistry, university of mansoura. the study will focus on one hundred class v restorations. no active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. the study is scheduled to be conducted from november 2023 to november 2025. the form and protocol of the study will be approved by mansoura university's ethics committee before initiation. to determine the appropriate sample size, previous studies examining the clinical success rate of posterior class v restorations restored with ion-releasing materials were considered. these studies reported a 100% success rate at a two-year follow-up. based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. considering a potential dropout rate of 20%, a sample size of 100 subjects was determined to be suitable.

Eligibility criteria:
inclusion criteria: * patients with one primary cervical caries on the buccal surface of any of their upper or lower posterior teeth. the cervical lesions must have an enamel margin occlusally and a cervical dentin margin * patients must have a good oral hygiene; * patients with tooth gives a positive response to testing with an electric pulp tester * patients with normal and full occlusion, * patients with opposing teeth should be natural with no restorations. exclusion criteria: - high caries risk patients with extremely poor oral hygiene, * patients involved in orthodontic treatment or periodontal surgery, * patients with periodontally involved teeth (chronic periodontitis) * patients with heavy bruxism habits and clenching
prevention of adhesions during celioscopy for endometriosis. impact of the use of anti-adhesion treatment on clinical signs and fertility at one year

Conditions: Endometriosis, Adhesive

Summary: thus is a longitudinal, prospective, multicentric observational study performed in mainland france, among a sample of gynaecology surgeons practising at endometriosis "expert" centres. the aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.


Eligibility criteria:
inclusion criteria: * adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery. * patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately. * patients accepting and able to update a questionnaire in french. * informed patients who agree to computerised processing of their medical data and their right of access and rectification. exclusion criteria: * patients for whom a medical assistance programme for procreation (ivf, artificial insemination) is currently in progress. * patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc). * patients not wishing to become pregnant. * patients participating or having participated during the previous month in a gynaecological clinical trial.

Keywords: coelioscopy
budesonide 9 mg capsules in active uc

Conditions: Colitis, Ulcerative

Summary: the purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis


Eligibility criteria:
inclusion criteria: * signed informed consent, * men or women aged 18 to 75 years, * active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology, * established disease, exclusion criteria: * crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis, * toxic megacolon or fulminant colitis, * colon resection, * evidence of infectious colitis (e.g., pathogenic bacteria or clostridium difficile toxin in stool culture at screening), * malabsorption syndromes, * celiac disease, * bleeding hemorrhoids, * active peptic ulcer disease * other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, * hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured, * any severe infectious disease (e.g., tuberculosis, aids), * severe co-morbidity substantially reducing life expectancy, * history of colorectal cancer, * history of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma
treatment of diabetes in patients with systolic heart failure

Conditions: Heart Failure, Systolic; Diabetes Mellitus, Type 2

Summary: investigator initiated study to study the effects of canagliflozin 100 milligrams (mg) vs sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption \[vo2\]) and ventilator efficiency (minute ventilation \[ve\]/carbon dioxide production \[vco2\] slope) at cardiopulmonary exercise test (cpet) after 12 weeks of active treatment (primary endpoints). blood pressure (bp), body water content, body composition, cardiac function, and diet will be also measured (secondary endpoints).

investigator initiated study: randomized, double-blinded, active-control clinical trial to determine the safety and efficacy of canagliflozin and sitagliptin in patients with type 2 diabetes and systolic heart failure (hf). the investigators propose to study the effects of canagliflozin 100 mg vs sitagliptin 100 mg (both administered once daily for 12 weeks) on parameters of aerobic exercise capacity and ventilator efficiency by cpet after 12 weeks of active treatment. bp, body water content (bioelectrical impedance analysis \[bia\]), body composition (dual-energy x-ray absorptiometry \[dexa\]), cardiac function, diet and biomarkers will be also measured. subjects with evidence of left ventricular hypertrophy will undergo cardiac magnetic resonance (cmr) imaging.

Eligibility criteria:
major inclusion criteria: * symptomatic stable heart failure (new york heart association (nyha) functional classification ii-iii) with reduced left ventricular ejection fraction (lvef) ≤40% * peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (rer) \>1.00 (reflecting maximal aerobic effort); * poorly controlled type 2 diabetes mellitus (t2dm)(hba1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen); * eighteen years of age or older. major exclusion criteria: * type i diabetes; * open label treatment with sodium-glucose cotransporter (sglt)-2 inhibitors (within the past 3 months); * current treatment with thiazolidinedione (within the past 3 months); * chronic renal disease defined as glomerular filtration rate (gfr) \<50 ml•min-1/1.73m2 according to local laboratory * pregnancy or of child-bearing potential or lactating; * active or recent (within 2 weeks) genital/urinary infection; * concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill * inability to give informed consent. exclusion criteria specific to the cardiac magnetic resonance (cmr) substudy. * estimated gfr \<60 ml•min-1/1.73m2 * implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with cmr scanning; * severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to cmr scanning.

Keywords: systolic heart failure canagliflozin sitagliptin phosphate type 2 diabetes sglt2 inhibitor dppiv inhibitor